Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045123
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2002-09-06
Brief Title:
R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence
Sponsor:
Myrexis Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase IIB Multicenter Randomized Double-Blind Placebo-Controlled Trial to Assess the Safety and Efficacy of MPC-7869 in Delaying the Systemic Progression of Prostate Cancer in Patients With Intermediate to High Risk of Recurrence With Rising PSA Levels After Prostatectomy Prostatectomy and Radiotherapy or Radiotherapy Alone for Localized Disease
Status:
UNKNOWN
Status Verified Date:
2004-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die R-flurbiprofen may be effective in delaying the recurrence of localized prostate cancer
PURPOSE Randomized phase II trial to study the effectiveness of R-flurbiprofen in treating patients who have localized prostate cancer at risk of recurrence following radiation therapy andor prostatectomy
PURPOSE Randomized phase II trial to study the effectiveness of R-flurbiprofen in treating patients who have localized prostate cancer at risk of recurrence following radiation therapy andor prostatectomy
Detailed Description:
OBJECTIVES
Determine the effect of R-flurbiprofen on time to systemic disease progression evaluated over a minimum of 3 years in patients with localized adenocarcinoma of the prostate with an intermediate or high risk of recurrence and rising prostate-specific antigen PSA levels after radiotherapy alone prostatectomy alone or both radiotherapy and prostatectomy
Determine the effect of this drug on the change in serum PSA levels over time prior to androgen-deprivation therapy ADT in these patients
Determine the effect of this drug on the time of initiation of ADT in these patients
Determine the effect of this drug on the number of patients requiring ADT
Determine the safety of this drug in these patients
Determine the population pharmacokinetics of R-flurbiprofen and bioinversion of R-ToS in this patient population
Determine the number of patients with systemic disease progression at the end of the study
Determine the time to clinical disease progression in patients treated with this drug
Determine the time to prostate cancer-related mortality and time to all cause mortality in patients treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to risk of recurrence based on Gleason score at diagnosis 5-7 vs 8-10 Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive oral low-dose R-flurbiprofen twice daily
Arm II Patients receive oral high-dose R-flurbiprofen twice daily
Arm III Patients receive oral placebo twice daily In all arms treatment continues for up to 55 years 66 months in the absence of disease progression or unacceptable toxicity Patients who demonstrate increased prostate-specific antigen without objective disease progression and require androgen-deprivation therapy ADT continue receiving R-flurbiprofen Patients who develop local recurrence or systemic disease may withdraw from study and receive additional therapy off study
PROJECTED ACCRUAL Approximately 390 patients 130 per treatment arm will be accrued for this study within 3 years
Determine the effect of R-flurbiprofen on time to systemic disease progression evaluated over a minimum of 3 years in patients with localized adenocarcinoma of the prostate with an intermediate or high risk of recurrence and rising prostate-specific antigen PSA levels after radiotherapy alone prostatectomy alone or both radiotherapy and prostatectomy
Determine the effect of this drug on the change in serum PSA levels over time prior to androgen-deprivation therapy ADT in these patients
Determine the effect of this drug on the time of initiation of ADT in these patients
Determine the effect of this drug on the number of patients requiring ADT
Determine the safety of this drug in these patients
Determine the population pharmacokinetics of R-flurbiprofen and bioinversion of R-ToS in this patient population
Determine the number of patients with systemic disease progression at the end of the study
Determine the time to clinical disease progression in patients treated with this drug
Determine the time to prostate cancer-related mortality and time to all cause mortality in patients treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to risk of recurrence based on Gleason score at diagnosis 5-7 vs 8-10 Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive oral low-dose R-flurbiprofen twice daily
Arm II Patients receive oral high-dose R-flurbiprofen twice daily
Arm III Patients receive oral placebo twice daily In all arms treatment continues for up to 55 years 66 months in the absence of disease progression or unacceptable toxicity Patients who demonstrate increased prostate-specific antigen without objective disease progression and require androgen-deprivation therapy ADT continue receiving R-flurbiprofen Patients who develop local recurrence or systemic disease may withdraw from study and receive additional therapy off study
PROJECTED ACCRUAL Approximately 390 patients 130 per treatment arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MYRIAD-MPR-7869-001 | None | None | None |